An argument that the system of boards that license human-subject
research is so fundamentally misconceived that it inevitably does more
harm than good.
Medical and social progress depend on research with human subjects. When
that research is done in institutions getting federal money, it is
regulated (often minutely) by federally required and supervised
bureaucracies called "institutional review boards" (IRBs).
Do--can--these IRBs do more harm than good? In The Censor's Hand,
Schneider addresses this crucial but long-unasked question.
Schneider answers the question by consulting a critical but ignored
experience--the law's learning about regulation--and by amassing
empirical evidence that is scattered around many literatures. He
concludes that IRBs were fundamentally misconceived. Their usefulness to
human subjects is doubtful, but they clearly delay, distort, and deter
research that can save people's lives, soothe their suffering, and
enhance their welfare. IRBs demonstrably make decisions poorly. They
cannot be expected to make decisions well, for they lack the expertise,
ethical principles, legal rules, effective procedures, and
accountability essential to good regulation. And IRBs are censors in the
place censorship is most damaging--universities.
In sum, Schneider argues that IRBs are bad regulation that inescapably
do more harm than good. They were an irreparable mistake that should be
abandoned so that research can be conducted properly and regulated
sensibly.